Evaluation of Treatment Safety and Efficacy in Hospitalized Patients with Mpox or Smallpox: A Multi-Institutional Collaborative Platform. sub-protocol01 Tecovirimat

Start Date01 Nov 2024

Sponsor / Collaborator-

NCT06156566

/ RecruitingPhase 4IIT

European Randomised Clinical Trial on mPOX Infection

The goal of this randomized controlled double-blind clinical trial is to test the drug tecovirimat in patients with mpox (previously known as monkeypox) disease.
The main questions it aims to answer are:
* Is tecovirimat effective in treating mpox infection.
* Is tecovirimat safe to treat patients with mpox infection.
Participants will receive either the drug tecovirimat orally, 600 mg twice per day, or a matching placebo. The outcome of the infection and the side effect experienced will be compared between the two groups.

Start Date09 Aug 2024

Sponsor / Collaborator

University of Antwerp

[+1]

NCT06721585

/ CompletedNot ApplicableIIT

A Randomized, Placebo-controlled, Double-blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Adult and Pediatric Patients With Monkeypox Virus Disease - Extension Amendment

The purpose of the PALM007 extension is to further characterize the clinical and natural history of mpox, and to provide standard of care (SOC) during the ongoing outbreaks.

Start Date10 Jul 2024

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

100 Clinical Results associated with Tecovirimat

100 Translational Medicine associated with Tecovirimat

100 Patents (Medical) associated with Tecovirimat

344

Literatures (Medical) associated with Tecovirimat

01 Mar 2026·Current Opinion in HIV and AIDS

Mpox therapeutics in the post-STOMP/PALM era

Review

Author: Brenner, Sara Bt ; Bortner, Adam C ; Ostrer, Lily ; Wilkin, Timothy J ; Promer, Katherine

Purpose of review:

This article reviews the evidence behind mpox antiviral therapies which are clinically available and/or or under clinical investigation. For much of the mpox epidemic, tecovirimat has been used compassionately but there is no evidence of its clinical efficacy.

Recent findings:

Multiple phase 3 placebo-controlled trials have failed to demonstrate clinical efficacy of tecovirimat in the treatment of mpox.

Summary:

This article summarizes the evidence behind current treatment recommendations including tecovirimat, brincidofovir, cidofovir, trifluridine, and VIGIV, as well as other investigational treatments.

09 Feb 2026·CLINICAL INFECTIOUS DISEASES

Mpox in People With HIV: Predictors of Diagnosis, Outcomes, and Vaccine Effectiveness in a Multisite Cohort

Article

Author: Pettit, April ; Delaney, Joseph A C ; Napravnik, Sonia ; Hunt, Peter W ; Whitney, Bridget M ; Keruly, Jeanne C ; Crane, Heidi M ; Christopoulos, Katerina A ; Montaño, Michalina ; Fredericksen, Rob J ; Shapiro, Adrienne E ; Kitahata, Mari M ; Saag, Michael S ; Moore, Richard D ; Kim, H Nina ; Mayer, Kenneth H ; Cachay, Edward R ; Yendewa, George A ; Burkholder, Greer ; Jacobson, Jeffrey M ; Bamford, Laura ; Bender Ignacio, Rachel A ; Eron, Joseph J

Abstract:

Introduction:

Since its global reemergence in 2022, monkeypox (mpox) has demonstrated increased incidence and severity among people with human immunodeficiency virus (HIV [PWH]). Predictors of mpox diagnosis, vaccination, and outcomes among PWH are limited.

Methods:

We included PWH with primary care visits after 1 January 2022 at 9 US sites participating in the Centers for AIDS Research Network of Integrated Clinic Systems Network. We identified mpox diagnosed between 1 June 2022 and 31 May 2023, through a combination of polymerase chain reaction result, diagnosis code, and/or tecovirimat receipt. We examined validated clinical diagnoses, laboratory results, vaccine data, and patient reported outcomes. We evaluated relative risks (RR) of mpox diagnosis, hospitalization, tecovirimat treatment, and vaccine receipt.

Findings:

Among 19 777 PWH in care, 413 mpox cases (all male sex at birth) occurred (2.2 cases/100 person-years). Age <40 years, geographic region, Hispanic/Latine ethnicity, lack of antiretroviral therapy, detectable HIV viral load, and recent bacterial sexually transmitted infection predicted mpox diagnosis. PWH with CD4 200–349 cells/mm3 were most likely to be hospitalized (adjusted RR, 3.20; 95% confidence interval: 1.44–7.09) compared to CD4 ≥500, but half as likely as those with CD4 <200 to receive tecovirimat. Overall, smallpox/mpox vaccine effectiveness of ≥1 vaccine was 71% (adjusted RR, 0.29; 95% confidence interval: .14–.47) at preventing mpox, and 86% or better with CD4 ≥350 or HIV viral suppression. Non-Hispanic Black PWH were less likely to be vaccinated than other racial/ethnic identities.

Interpretation:

PWH not on antiretroviral therapy or with unsuppressed HIV were more likely to be diagnosed with, and hospitalized for, mpox. Mpox/smallpox vaccine effectiveness was high, inclusive of those with low CD4 count and HIV viremia.

01 Feb 2026·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Ligand-based design and optimization of tecovirimat derivatives as potent antiviral agents against monkeypox virus

Article

Author: Zhang, Xumu ; Zheng, Peisen ; Liu, Yongqing ; Zhou, Xingyu ; Deng, Xinshan ; Liang, Dizhen ; Li, Guanguan ; Yang, Sumei ; Zhou, Qifan ; Liu, Xiang ; Chen, Yuanguang ; Yi, Hongyang ; Lu, Hongzhou

Among orthopoxviruses, monkeypox virus (MPXV) is currently the most significant human pathogen due to ongoing outbreaks and global spread. Tecovirimat, an FDA-approved antiviral for orthopoxviruses, inhibits the viral p37 protein essential for viral egress and is used under expanded access for monkeypox treatment. To develop more accessible inhibitors and enhance structure-activity relationship (SAR) research, a new library of tecovirimat derivatives has been designed and synthesized. These compounds underwent phenotype determination to evaluate their antiviral properties, leading to the identification of C12 (EC₅₀ = 12.14 nM, CC₅₀ = 304.63 μM) as a promising lead compound. C12 demonstrated stable high plasma exposure following oral administration in mice, achieving a bioavailability (F) of 162 % and extensive distribution within the plasma. It also demonstrated low toxicity and good tolerability in mice, with a single dose of 2000 mg/kg or repeated doses of 100 mg/kg once daily for 14 days. Additionally, the P37 protein structure of VACN was employed for molecular docking to investigate potential binding interactions. Computational simulations suggest that C12 targets the same protein as tecovirimat, offering valuable insights for the rational design of next-generation analogs.

133

News (Medical) associated with Tecovirimat

12 Feb 2026

·www.biospace.com

MPox Orphan Drug Designation Application Filed for NV-387, Declares NanoViricides

SHELTON, CONNECTICUT / ACCESS Newswire / February 12, 2026 / NanoViricides, Inc., a publicly traded company (NYSE American: NNVC ) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announced today that it has filed an application for Orphan Drug Designation (ODD) for "NV-387 as a Treatment for MPox" with the US FDA Office of Orphan Products Development (OOPD). If approved, orphan drug designation will qualify NanoViricides for incentives including: Tax credits for qualified clinical trials; Exemption from certain user fees; Potential seven years of market exclusivity after approval; according to the US FDA ( ). "NV-387, as an effective drug would be an important tool to fight MPox in the USA and worldwide, when approved after clinical trials," said Anil R. Diwan, PhD, adding, "MPXV clade IIb is endemic in the USA. Further, the more contagious MPXV Clade Ia/Ib continues to simmer in Africa and is mutating, posing a potential global pandemic threat." WHO had declared a "Public Health Emergency of International Concern" (PHEIC) for MPox in 2022 due to the spread of MPXV Clade II into Western countries, ending it about a year later. A new PHEIC was declared by WHO again in August, 2024, due to the spread of MPox Clade Ia/Ib in African region, ending it in September, 2025. However, the Africa CDC has continued the declaration of the MPox pandemic in African Region as Public Health Emergency of Continental Security ("PHECS"), due to continued spread of the MPXV virus. MPox disease is caused by infection with MPXV (Monkeypox Virus) virus. While earlier MPXV infections were related to zoonotic (i.e. from animals) transmission to humans, the virus has evolved to a highly contagious form, MPXV Clade Ib, in recent years with continuous human-to-human transmission. MPXV is closely related to Variola virus that causes Smallpox in humans. Smallpox is a far more severe and lethal disease compared to MPox. Smallpox was globally eradicated by 1980 by an aggressive vaccination campaign with an effective vaccine that provides lifelong immunity. This success is founded in the fact that Smallpox is restricted to humans and has no animal reservoirs, unlike MPox which has many animal reservoirs. Smallpox continues to be a bio-terrorism concern. There is no approved drug for the treatment of MPox. Tecovirimat (TPOXX®, SIGA) and brincidofovir (TEMBEXA®, EBS) were approved by the US FDA for Smallpox, both under the "Animal Rule". Tecovirimat has failed to show any clinical effectiveness, and did not show any viral load reduction benefit either, over standard of care in a clinical trial for treatment of MPXV infections 1 . Mutants resistant to tecovirimat were found to be generated in some cases. Brincidofovir treatment resulted in drug-induced liver disease in three out of three treated MPox patients resulting in cessation of therapy, and did not show any effectiveness in these patients according to a peer reviewed "retrospective observational study" also called "non-randomized study" 2 . In spite of this, a clinical trial of brincidofovir for treating MPox was initiated under an international coalition led by US CDC and first patient was dosed around January 2025 in this "MOSA" clinical trial 3 . The topline results from this clinical trial regarding safety and efficacy were anticipated by CY Q2 (i.e. June, 2025). We have not found any press releases announcing any such results. The orthopoxviruses can escape both small chemical drugs, tecovirimat and brincidofovir, by mutations, according to peer reviewed scientific articles 4 . MPXV has continued to mutate in the African region. Mutants resistant to the JYNNEOS® Smallpox vaccine that was fielded to control the spread of MPXV Clade Ia/Ib have been found. The antibody response to MPXV from the JYNNEOS vaccine was found to be poor and short-lived 5 . The above factors clearly highlight the need for an effective therapeutic for the treatment of MPOX. NV-387 has shown strong effectiveness in a mouse model of dermal lethal infection of ectromelia, an orthopoxvirus closely related to viruses that cause smallpox and mpox. NV-387 has successfully completed a Phase I human clinical trial demonstrating safety and tolerability in healthy adults with no reported adverse events. Therefore the Company believes that NV-387 is a viable clinical candidate for the treatment of MPox. In the USA, MPOX incidence rate was approximately 2,042 cases in 2025, well below 200,000 cases 6 . Thus NV-387 for the Treatment of MPox qualifies for Orphan Drug Designation. NanoViricides employed the expert services of Only Orphans Cote, LLC, ("OOC") a regulatory consultant firm founded by Dr. Timothy Cote, for developing the ODD application. Dr. Timothy Cote previously served as the Director of US FDA Office of Orphan Products Development (OOPD), and has intimate knowledge of the laws, rules, and regulations, governing orphan drugs, and the potential benefits to the Drug Sponsors. NV-387 is an unusually broad-spectrum antiviral drug that has demonstrated strong effectiveness in relevant animal models of multiple human viral infections. These include RSV, COVID, Influenza, Mpox, Smallpox, and Measles. Viral resistance to NV-387 is unlikely because this drug mimics specific cell-side features that these viruses continue to employ to effectively infect human host cells, despite how much they may change in the field. In contrast, viruses mutations readily result in making traditional vaccines, antibodies, and small chemical drugs ineffective. Further, NV-387 is a complete chemical nanomachine that completes the task of binding to, engulfing, and destroying virus particles without any dependence on the human immune system. These factors make NV-387 unique in the field of antiviral drugs and vaccines. ABOUT NANOVIRICIDES NanoViricides, Inc. (the "Company") ( ) is a publicly traded (NYSE-American, stock symbol NNVC) clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide ™ class of drug candidates and the nanoviricide ™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments. The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005. Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials. The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour ® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product. This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products. The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA. FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development. Contact: NanoViricides, Inc. info@nanoviricides.com Public Relations Contact: ir@nanoviricides.com 1 The PALM007 Writing Group, "Tecovirimat for Clade I MPXV Infection in the Democratic Republic of Congo", N Engl J Med 2025;392:1484-96. DOI: 10.1056/NEJMoa2412439. 2 Adler H. et al., "Clinical features and management of human monkeypox: a retrospective observational study in the UK", Lancet Infect Dis 2022; 22: 1153-62, Published Online May 24, 2022, corrected May 26, S1473-3099(22)00228-6. NHS England High Consequence Infectious Diseases (Airborne) Network . 3 . 4 Becker et al - RW Moyer group "Isolation and characterization of cidofovir resistant vaccinia viruses", Virology Journal 2008, 5:58 doi:10.1186/1743-422X-5-58. Brincidofovir is a prodrug of cidofovir, which means cellular enzymes convert it to cidofovir. 5 Phipps, K. et al. "Short-Lived Neutralizing Antibody Responses to Monkeypox Virus in Smallpox Vaccine-Naive Persons after JYNNEOS Vaccination." Wadsworth Center, New York State Department of Health and Univ. of Albany, NY. Emerging Infectious Diseases • • Vol. 31, No. 2, February 2025. DOI: . 6 . SOURCE: NanoViricides, Inc. View the original press release on ACCESS Newswire

Phase 1Clinical ResultDrug ApprovalLicense out/inOrphan Drug

28 Jul 2025

·www.globenewswire.com

New Publication in Expert Review of Anti-infective Therapy Evaluates Brincidofovir as Potential Antiviral Treatment for Mpox

Ongoing mpox outbreak continues to be a global health threat and is driving need for greater therapeutic research and innovationGAITHERSBURG, Md., July 28, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced the publication of a comprehensive review article, "Brincidofovir in the Era of Mpox," in the peer-reviewed journal Expert Review of Anti-infective Therapy.1 This publication includes an overview of brincidofovir, in vitro and in vivo data, including human case studies of the investigational use of brincidofovir, the current evaluation for treating mpox infections in adults and pediatrics in the Democratic Republic of Congo, and the potential for combination therapy with tecovirimat for immunocompromised patients with severe disease. “We believe in the importance of assessing brincidofovir, an antiviral, for this public health threat and we look forward to advancing our research across mpox as it’s a global disease of increasing concern,” said Simon Lowry, M.D., chief medical officer and head of research and development at Emergent. Mpox, formerly known as monkeypox, continues to pose a significant public health challenge, with ongoing regional and global outbreaks particularly in Central and West Africa. On August 14, 2024, the World Health Organization (WHO) declared the current mpox outbreak a global Public Health Emergency of International Concern (PHEIC).2 This marks the second mpox PHEIC declared by the WHO in the past two years, which followed the regional emergency declaration by the Africa Centres for Disease Control and Prevention (Africa CDC) on August 13, 2024.3 This month, the U.S. Centers for Disease Control and Prevention issued an updated report on the surge of mpox around the world.4 As part of the ongoing effort to identify safe and effective treatments for mpox, brincidofovir is currently being evaluated by the Africa CDC in partnership with PANTHER (PANdemic preparedness plaTform for Health and Emerging infectious Response) in the MpOx Study in Africa (MOSA), a double-blind, placebo-controlled clinical trial for people diagnosed with mpox, which initiated in January 2025. The study has received initial funding from Horizon Europe and Africa CDC. Dr. Lowry continued, “In addition to our engagement with PANTHER on the MOSA trial, this scientific review provides insights into the investigational use of brincidofovir in the treatment of mpox, and we are pleased this publication is available for the broader medical community.” Please see full Prescribing Information for TEMBEXA® (brincidofovir) for additional safety information.About Emergent BioSolutions At Emergent, our mission is to protect and save lives. For over 25 years, we’ve been at work preparing those entrusted with protecting public health. We deliver protective and life-saving solutions for health threats like smallpox, mpox, botulism, Ebola, anthrax and opioid overdose emergencies. To learn more about how we help prepare communities around the world for today’s health challenges and tomorrow’s threats, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify. Safe Harbor StatementWe generally identify forward-looking statements by using words like “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “should,” “will,” “would,” and similar expressions or variations thereof, or the negative thereof, but these terms are not the exclusive means of identifying such statements. Forward-looking statements are based on our current intentions, beliefs, and expectations regarding future events based on information that is currently available. We cannot guarantee that any forward-looking statement will be accurate. Readers should realize that if underlying assumptions prove inaccurate or if known or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events, or circumstances. Readers should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the U.S. Securities and Exchange Commission, when evaluating our forward-looking statements. Investor Contact:Richard S. LindahlExecutive Vice President, CFOlindahlr@ebsi.com Media Contact:Assal HellmerVice President, Communicationsmediarelations@ebsi.com __________________________ 1 https://doi.org/10.1080/14787210.2025.25320292 https://www.who.int/news/item/14-08-2024-who-director-general-declares-mpox-outbreak-a-public-health-emergency-of-international-concern3 https://africacdc.org/news-item/africa-cdc-declares-mpox-a-public-health-emergency-of-continental-security-mobilizing-resources-across-the-continent/ 4 https://www.cdc.gov/mpox/situation-summary/index.html

Clinical Study

08 Apr 2025

·www.globenewswire.com

SIGA Declares Special Cash Dividend of $0.60 Per Share

NEW YORK, April 08, 2025 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (Nasdaq: SIGA), a commercial-stage pharmaceutical company, today announced that its board of directors declared a special cash dividend of $0.60 per share on the company’s common stock. This represents the fourth straight year of a special cash dividend. The amount of the dividend declared is consistent with the level of the dividend declared in March 2024. The dividend is payable on May 15, 2025, to shareholders of record at the close of business on April 29, 2025. “Today’s announcement of a special cash dividend reflects the strength of our balance sheet and continued confidence in the future of our business,” said Diem Nguyen, Chief Executive Officer. “As we look ahead, we remain committed to disciplined financial management and strategic execution to drive long-term shareholder value.” ABOUT SIGA SIGA is a commercial-stage pharmaceutical company and leader in global health focused on the development of innovative medicines to treat and prevent infectious diseases. With a primary focus on orthopoxviruses, we are dedicated to protecting humanity against the world’s most severe infectious diseases, including those that occur naturally, accidentally, or intentionally. Through partnerships with governments and public health agencies, we work to build a healthier and safer world by providing essential countermeasures against these global health threats. Our flagship product, TPOXX® (tecovirimat), is an antiviral medicine approved in the U.S. and Canada for the treatment of smallpox and authorized in Europe, the UK, and Japan for the treatment of smallpox, mpox (monkeypox), cowpox, and vaccinia complications. For more information about SIGA, visit www.siga.com. FORWARD-LOOKING STATEMENTS This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements relating to SIGA’s future business development and plans. Forward-looking statements include statements regarding our future financial position, business strategy, budgets, projected costs, plans and objectives of management for future operations. The words “may,” “continue,” “estimate,” “intend,” “plan,” “will,” “believe,” “project,” “expect,” “seek,” “anticipate,” “could,” “should,” “target,” “goal,” “potential” and similar expressions may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Such forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that any forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. SIGA’s actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors, some of which are beyond SIGA’s control, including, but not limited to, (i) the risk that SIGA may not complete performance under the 75A50118C00019 BARDA Contract (the “BARDA Contract”) on schedule or in accordance with contractual terms, (ii) the risk that the BARDA Contract or U.S. Department of Defense contracts are modified or canceled at the request or requirement of, or SIGA is not able to enter into new contracts to supply TPOXX to, the U.S. Government, (iii) the risk that the nascent international biodefense market does not develop to a degree that allows SIGA to continue to successfully market TPOXX internationally, (iv) the risk that potential products, including potential alternative uses or formulations of TPOXX that appear promising to SIGA or its collaborators, cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (v) the risk that target timing for deliveries of product to customers, and the recognition of related revenues, are delayed or adversely impacted by the actions, or inaction, of contract manufacturing organizations, or other vendors, within the supply chain, or due to coordination activities between the customer and supply chain vendors, (vi) the risk that SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products or uses, (vii) the risk that SIGA may not be able to secure or enforce sufficient legal rights in its products, including intellectual property protection, (viii) the risk that any challenge to SIGA’s patent and other property rights, if adversely determined, could affect SIGA’s business and, even if determined favorably, could be costly, (ix) the risk that regulatory requirements applicable to SIGA’s products may result in the need for further or additional testing or documentation that will delay or prevent SIGA from seeking or obtaining needed approvals to market these products, (x) the risk that the volatile and competitive nature of the biotechnology industry may hamper SIGA’s efforts to develop or market its products, (xi) the risk that changes in domestic or foreign economic and market conditions may affect SIGA’s ability to advance its research or may affect its products adversely, (xii) the effect of federal, state, and foreign regulation, including drug regulation and international trade regulation, including tariffs, on SIGA’s businesses, (xiii) the risk of disruptions to SIGA’s supply chain for the manufacture of TPOXX®, causing delays in SIGA’s research and development activities, causing delays or the re-allocation of funding in connection with SIGA’s government contracts, or diverting the attention of government staff overseeing SIGA’s government contracts, (xiv) risks associated with actions or uncertainties surrounding the debt ceiling, and (xv) the risk that the U.S. or foreign governments' responses (including inaction) to national or global economic conditions or infectious diseases, are ineffective and may adversely affect SIGA’s business, as well as the risks and uncertainties included in Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2024 and SIGA's subsequent filings with the Securities and Exchange Commission. SIGA urges investors and security holders to read those documents free of charge at the SEC's website at http://www.sec.gov. All such forward-looking statements are current only as of the date on which such statements were made. SIGA does not undertake any obligation to update publicly any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events. Contacts:Suzanne Harnettsharnett@siga.com and InvestorsJennifer Drew-Bear, Edison GroupJdrew-bear@edisongroup.comMediaHolly Stevens, CG Lifehstevens@cglife.com

100 Deals associated with Tecovirimat

External Link

KEGG	Wiki	ATC	Drug Bank
D09390	Tecovirimat	J05AX24	DB12020

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Vaccinia	United Kingdom	SIGA Technologies, Inc.	08 Jul 2022
Cowpox	European Union	SIGA Technologies, Inc.	06 Jan 2022
Cowpox	Iceland	SIGA Technologies, Inc.	06 Jan 2022
Cowpox	Liechtenstein	SIGA Technologies, Inc.	06 Jan 2022
Cowpox	Norway	SIGA Technologies, Inc.	06 Jan 2022
Monkeypox	European Union	SIGA Technologies, Inc.	06 Jan 2022
Monkeypox	Iceland	SIGA Technologies, Inc.	06 Jan 2022
Monkeypox	Liechtenstein	SIGA Technologies, Inc.	06 Jan 2022
Monkeypox	Norway	SIGA Technologies, Inc.	06 Jan 2022
Smallpox	United States	SIGA Technologies, Inc.	13 Jul 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Morgellons Disease	Phase 2	United States	SIGA Technologies, Inc.	01 Jun 2009
Orthopoxvirus infection	Preclinical	United States	SIGA Technologies, Inc.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05534984 (STOMP, CTgov)	Phase 3	Monkeypox	719	Tecovirimat Oral Capsule (Tecovirimat (Arm A))	nbtkhrqgby = tpifampzfq vebbqhdgjt (opkplitwna, qqqljauzax - lnbuqpdawa) View more	-	10 Feb 2026
				Placebo (Placebo (Arm B))	nbtkhrqgby = mebbyjotxo vebbqhdgjt (opkplitwna, gwljwmmrng - wssfrdjsdw) View more
NCT05559099 (PALM007 \| PALM 007, CTgov)	Phase 2	Monkeypox	597	Tecovirimat Oral Capsule (Tecovirimat)	otcdnwqfvl(ajubrcghvz) = rgylkrceal pkbkfmjvmy (nrqpgvblvp, znuafutehi - dlwwjvuamm) View more	-	09 Oct 2025
				Placebo (Placebo)	otcdnwqfvl(ajubrcghvz) = tbiyllfqqs pkbkfmjvmy (nrqpgvblvp, pfoulrxdhh - ltjhyusylq) View more
NCT05559099 (PALM007, Pubmed \| N Engl J Med)	Phase 2	Monkeypox clade I MPXV	597	Tecovirimat	ivisvfpthu(dirgpcqoom) = wolvsetima ubmqojdyxn (jjrsejlzcg ) View more	Negative	17 Apr 2025
				Placebo	ivisvfpthu(dirgpcqoom) = noskjalful ubmqojdyxn (jjrsejlzcg ) View more
NCT05534984 (STOMP, GlobeNewswire) Manual	Phase 3	Monkeypox	-	tecovirimat	lvpwdkpgsh(wjrryixvcq) = NIAID reported that SIGA’s tecovirimat, a highly targeted antiviral treatment, did not demonstrate efficacy in time to skin and mucosal lesion resolution compared to placebo in patients with mild to moderate clade II mpox. sfkvadresw (srwqohyjuo )	Negative	10 Dec 2024
				placebo
NCT04971109 (CTgov)	Phase 3	Smallpox	467	TPOXX (TPOXX)	uwldghvbjx = omjjnxxxem vurqugjicm (jaglvylbja, zniucpboyw - gqhmsxsfas) View more	-	23 Oct 2024
				TPOXX Placebo (TPOXX Placebo)	uwldghvbjx = xeowbzjben vurqugjicm (jaglvylbja, oxiqoklgup - gzidefdiga) View more
NCT04485039 (CTgov)	Phase 4	Smallpox	44	Tecovirimat (TPOXX: Oral Antiviral)	sngwnemlio(odfzluphiy) = ougpxrsbbf kxvzrefrfg (izscdkprpk, 39.6) View more	-	09 Oct 2024
				Tecovirimat+sevelamer carbonate oral tablet (TPOXX: Oral Antiviral and Sevelamer Carbonate)	earrawmmpo(tcxfienpqy) = kopajhmusa rfccjxlvqu (zsbvhupagi, zoolkbhzep - twngcbjbyp) View more
NCT04392739 (CTgov)	Phase 4	Smallpox	34	Tpoxx	gohfwnrnfe(rdlhlassti) = jppczsrwxs hjwofkznni (czkjovblfm, 26.0) View more	-	19 Sep 2024
NCT05559099 (PALM 007, GlobeNewswire) Manual	Phase 2	Monkeypox	-	Tecovirimat + SOC	euxkvdkwzb(vcsucgwtvk) = not superior to placebo in lesion resolution for all patients ieczvnqsrb (xmivfkadnw ) Not Met View more	Negative	15 Aug 2024
				Placebo + SOC
NCT02474589 (SIGA246-008, CTgov)	Phase 3	Smallpox	449	tecovirimat (Active)	tjkneyydla = ajgeklwlpb mmkhouluik (kahctshvwi, ubtstocigo - lqupusxhir) View more	-	28 Nov 2017
				Placebo (Placebo)	tjkneyydla = olirxcarfa mmkhouluik (kahctshvwi, tmlvjiuqpk - srsjtyhgeo) View more
NCT00907803 (246-Safety, CTgov)	Phase 2	Morgellons Disease	107	ST-246 400 mg (ST-246 400 mg)	rxugzdazys = fmenirrfpc uvrtcarlai (petyklqsaw, qjggpougll - dwttdihzvm) View more	-	27 Aug 2010
				ST-246 600 mg (ST-246 600 mg)	rxugzdazys = znyvsgrqxq uvrtcarlai (petyklqsaw, gcsmwmbveh - bqulyltcoc) View more

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